Vivek Ramaswamy recruits Eli Lilly R&D vet Salzmann as new CEO; Axovant drops collaboration
→ Vivek Ramaswamy has recruited Eli Lilly R&D vet Pete Salzmann to take the helm at one of his new vants. Salzmann is the new CEO at Immunovant, which is working on IMVT-1401, a monoclonal antibody in development for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Salzmann had been in charge of the development program for Olumiant (baricitinib), which proved troublesome for Eli Lilly as regulators raised serious concerns about safety.
→ A couple of weeks after updating their plans for their new spin-off company, first announced last year, UK-based Mallinckrodt — the maker of the controversial drug Acthar — announced today that it has “reached an agreement with the US DoJ to resolve the previously disclosed government investigation of Questcor’s legacy sales and marketing activities, which is still subject to the finalization of certain terms.”
The company says that the government is trying to recover monetary damages — allegedly made by the legacy Questcor charitable foundation between 2010 and 2014 — for alleged violations of the False Claims Act and the Anti-Kickback Statute.
“Contrary to the DOJ’s characterizations in the complaint, the allegations relate to legacy Questcor conduct as all the donations to the Chronic Disease Fund (CDF) referenced in the complaint occurred prior to the acquisition of Questcor or were for grandfathered patients who had been approved by CDF for co-pay assistance prior to the acquisition. Mallinckrodt acquired Questcor in August 2014.”
The company expects to pay $15.4 million in relation to legacy Questcor activities.
→ Axovant is dropping its license and collaboration agreement with Benitec Biopharma — which included AXO-AAV-OPMD, treatment of oculopharyngeal muscular dystrophy (OPMD), and discovery stage research collaboration programs — in its entirety.
In addition, Axovant reported six-month follow-up data for its gene therapy, AXO-Lenti-PD — a treatment for Parkinson’s disease — from the first dose cohort in the open-label, dose-escalation portion of its ongoing SUNRISE-PD Phase II trial. The company noted that there were “no serious adverse events related to the product or procedure” and that patients were continuing to show improvement from baseline across multiple measurements.